FDA-Device2025-03-19Class II
Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334;
Hazard
Multiple problems identified with the software version leading to various scanning and image issues, and unintended device movement.
Sold states
Domestic: MN
Affected count
1 unit
Manufactured in
Veenpluis 6, Best, Netherlands
Products
Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1324-2025More Philips Medical Systems Nederland B.V. recalls
- FDA-Device2026-06-03Philips Azurion imaging systems recalled for hard drive failure risk affecting imaging functionality
- FDA-Device2026-06-03Philips Allura medical imaging systems recalled for hard drive failure risk
- FDA-Device2026-05-27Philips Azurion X-ray systems recalled for cooling hose degradation risk
- FDA-Device2026-05-27Philips Integris-Allura X-ray systems recalled for cooling unit oil leakage risk
- FDA-Device2026-05-27Philips Azurion X-ray systems recalled for impaired table movement due to control wear
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